MATVAC-1 : EVALUATION OF UCPVAX VACCINE +/- PEMBROLIZUMAB COMBINED WITH STANDARD TREATMENT AS ADJUVANT THERAPY IN PATIENTS WITH UNMETHYLATED MGMT GLIOBLASTOMA

Conditions

Glioblastoma

Brief summary

In each experimental arms, the primary endpoint for the efficacy is the rate of patients alive at 18 months post randomization

Detailed description

The rate of patients alive at 18 months post randomization, Overall survival (OS) defined as the time interval from randomization to the date of death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period, Progression free survival (PFS) according to RANO 2.0 criteria: defined as the time interval from the date of randomization to the date of first documented disease progression or death from any cause, whichever occurs first. Alive patients without progression will be censored at last radiological evaluation showing no progression during study treatment follow-up., Adverse events and routine lab abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0, see Appendix 2), timing, seriousness and relationship to study treatments at each visit., Immunogenecity will be assess by ex vivo IFN-γ ELISpot in peripheral blood (Adotevi JCO 2023)., Health related Quality of life will be evaluated with EORTC-QLQC30 questionnaire and BN20 module at randomization and at 6 months.

Related papers

No related papers found yet.

Interventions

DRUGPEMBROLIZUMAB

DRUGUCPVax 1mg/2ml

DRUGTEMOZOLOMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
In each experimental arms, the primary endpoint for the efficacy is the rate of patients alive at 18 months post randomization	—

Secondary

Measure	Time frame
The rate of patients alive at 18 months post randomization, Overall survival (OS) defined as the time interval from randomization to the date of death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period, Progression free survival (PFS) according to RANO 2.0 criteria: defined as the time interval from the date of randomization to the date of first documented disease progression or death from any cause, whichever occurs first. Alive patients without progression will be censored at last radiological evaluation showing no progression during study treatment follow-up., Adverse events and routine lab abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0, see Appendix 2), timing, seriousness and relationship to study treatments at each visit., Immunogenecity will be assess by ex vivo IFN-γ ELISpot in peripheral blood (Adotevi JCO 2023)., Health related Quality of	—

Measure

Time frame

The rate of patients alive at 18 months post randomization, Overall survival (OS) defined as the time interval from randomization to the date of death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period, Progression free survival (PFS) according to RANO 2.0 criteria: defined as the time interval from the date of randomization to the date of first documented disease progression or death from any cause, whichever occurs first. Alive patients without progression will be censored at last radiological evaluation showing no progression during study treatment follow-up., Adverse events and routine lab abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0, see Appendix 2), timing, seriousness and relationship to study treatments at each visit., Immunogenecity will be assess by ex vivo IFN-γ ELISpot in peripheral blood (Adotevi JCO 2023)., Health related Quality of

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Countries

France

Outcome results

None listed